Atlas FDA

JRM

7 FDA 510(k) clearances · Product code

68 daysmedian time to decision
151 days90th percentile
7clearances measured

FDA profile

Official device name
Freezer
Device class
Class I (low risk)
Regulation
21 CFR 862.2050
Medical specialty
Clinical Chemistry
Flags
GMP exempt
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RecordFirmDate
ORS-100 (K921568)Mnlase, Inc.1992-06-09
ORS-200 (K921569)Mnlase, Inc.1992-06-09
ORS-300 (K921570)Mnlase, Inc.1992-06-09
ORS-1000 (K915427)Mnlase, Inc.1992-01-07
SELF-CONTAINED SURGICAL SLUSH FREEZER (K913777)Taylor Corp.1991-09-25
SANISERV SURGICAL SLUSH SYSTEM (K894006)Saniserv, Inc.1989-11-03
LANCER ICE CUBE (K782077)Sherwood Medical Industries1979-04-03

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Every clearance here is in the API, with alerts when new ones post.